TROCENDO: Screening for Hepatitis C Using a Rapid Diagnostic Orientation Test (TROD) in Patients Over 50 Years Old in the Digestive Endoscopy Department of the Europeen Hospital Marseille

Sponsor
Hôpital Européen Marseille (Other)
Overall Status
Recruiting
CT.gov ID
NCT05103085
Collaborator
(none)
5,000
1
19.2
260.1

Study Details

Study Description

Brief Summary

Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the French High Authority of Health, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular drug users, people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who are or have beenincarcerated .

French government recommendations aim to achieve elimination of hepatitis C virus HCV (as early as 2025) and since April 2018 the European Hospital Marseille is engaged in this battle and organizes every year "the day without hepatitis" in the hospital.

Since 2017, direct-acting antiviral treatments have become available in France to all patients infected with HCV, regardless of the degree of severity of their disease. These treatments are effective in more than 95% of cases and, in 2019, 18,000 people were cured. As of today, it is estimated that there are still 110,000 people likely to be treated in France. Among them, 75,000 are unaware of being HCV positive, people who need to be tested.

With one of the largest volumes of digestive endoscopic examinations in France, the European Hospital Marseille may be a significant source of screening for hepatitis C.

Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in the endoscopy department at the European Hospital Marseille.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Rapid diagnostic orientation test (TROD) for Hepatitis C

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Screening for Hepatitis C Using a Rapid Diagnostic Orientation Test (TROD) in Patients Over 50 Years Old in the Digestive Endoscopy Department of the Europeen Hospital Marseille
Actual Study Start Date :
Jan 24, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental

Patient undergoing digestive endoscopy and aged 50 years and over

Diagnostic Test: Rapid diagnostic orientation test (TROD) for Hepatitis C
Inclusion of patients during the consultation with the gastroenterologist, before hospitalization in the digestive endoscopy department. Each consenting patient benefits from a HCV screening using TROD on the day of their hospitalization in the department.

Outcome Measures

Primary Outcome Measures

  1. Number of patients aged 50 and over tested positive for chronic viral hepatitis C during gastrointestinal endoscopy. [16 months]

Secondary Outcome Measures

  1. Number of patients who refuse viral screening [16 months]

  2. Investigation and identification of potential risk factors in patients diagnosed positive for chronic viral hepatitis C [16 months]

  3. Number of viremic patients without risk factor [16 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Aged ≥ 50

  • Giving free and informed written consent

  • Being affiliated with or benefiting from a social security scheme

Exclusion Criteria:
  • Patient unable to express consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Européen Marseille Marseille France 13003

Sponsors and Collaborators

  • Hôpital Européen Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital Européen Marseille
ClinicalTrials.gov Identifier:
NCT05103085
Other Study ID Numbers:
  • 21-24
First Posted:
Nov 2, 2021
Last Update Posted:
Feb 10, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022